Protocol summary

Summary
In this study 32 people with nonspecific chronic low back pain, without spinal surgery or fracture, classified based on O'Sullivan classification system will put in 2 treatment group randomly ( Stabilization exercise vs movement exercise). The aim of this study is to compare effect of these exercise protocol on pain, trunk muscle activity and postural control.Patient will be treated in 10 treatment sessions and the length of treatment is 4 weeks( 1 month). Trunk muscles activity level and postural control will be measured by surface electromyography and force plate before and after treatment. Also pain and functional level of patents will asses with VAS and oswestry questionnaire before and after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121615822N1
Registration date: 2015-03-15, 1393/12/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-15, 1393/12/24
Registrant information
Name
Sara Salamat
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7768 5088
Email address
salamat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rehabilitation School of Tehran University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of movement control exercises and stabilization exercises on trunk muscle activity and postural control in people with nonspecific chronic low back pain
Public title
Effect of two exercise therapy on low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18-65 ; Non specific chronic low back pain; pain in the directions of Flex and Ext based on O'Sullivan classification system Exclusion criteria: Inflammatory and infectious diseases of spine; RA; Fracture; pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rehabilitation School of Tehran University of Medical Sciences
Street address
Enghelab St, Rehabilitation School of Tehran University of Medical Sciences, Tehran
City
Tehran
Postal code
Approval date
2013-05-18, 1392/02/28
Ethics committee reference number
297/130/د/92

Health conditions studied

1

Description of health condition studied
low back pain
ICD-10 code
M54.5
ICD-10 code description
low back pain

Primary outcomes

1

Description
Muscle activity level
Timepoint
Beginning of the study and the day 30th
Method of measurement
Surface electromyography

2

Description
Balance
Timepoint
Beginning of the study and the day 30th
Method of measurement
Force plate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group one: Stabilization exercises, 10 therapeutic sessions,4 weeks
Category
Rehabilitation

2

Description
Intervention group 2: Movement control exercises, !0 therapeutic sessioms, 4 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation School of Tehran University of Medical Sciences
Full name of responsible person
Sara salamat
Street address
Rehabilitation School of Tehran University of Medical Science, Enghelab St, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rehabilitation School of Tehran University of Medcal Sciences
Full name of responsible person
Saeed Talebian Moghadam
Street address
Rehabilitation School of Tehran University of Medical Sciences, Enghelab st, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rehabilitation School of Tehran University of Medcal Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rehabilitation School of Tehran University of Medical Sciences
Full name of responsible person
Saeed Talebian Moghadam
Position
Supervisor/professor of physiotherapy
Other areas of specialty/work
Street address
Rehabilitation School of Tehran Univrsity of Medical Science, Enghelab St, Tehran
City
Tehran
Postal code
Phone
+98 21 7768 5088
Fax
Email
talebian@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehabilitation School of Tehran University of Medical Sciences
Full name of responsible person
Sara Salamat
Position
Physiotherapy Phd student
Other areas of specialty/work
Street address
Rehabilitation School of Tehran University of Medical Sciences, Enghelab St, Tehran
City
Tehran
Postal code
Phone
+98 21 7768 5088
Fax
Email
salamat@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation School of Tehran University of Medical Sciences
Full name of responsible person
Sara Salamat
Position
physiotherapy Phd student
Other areas of specialty/work
Street address
Rehabilitation School of Tehran University of Medical Sciences, Enghelab St, Tehran
City
Tehran
Postal code
Phone
+98 21 7768 5088
Fax
Email
salamat@ razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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